- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00969046
Dose-Escalation Study in Advanced Colon Cancer Patients
December 6, 2020 updated by: Novartis Pharmaceuticals
EPO906 Phase I 6-arm Trial to Optimize Administration Exploring Single Dose Bolus and Continuous Infusion Over 1 or 5 Days Every 3 or 4 Weeks in Patients With Pretreated Advanced Colon Cancer With Nutritional Support Treatment and Intensive Management of Diarrhea
This study is exploring different administration schedules (short versus prolonged infusion) to optimize the safety and efficacy profile of EPO906A (patupilone) in patients with pretreated advanced colon cancer.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hradec Králové, Czechia
- Novartis Investigative Site
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Prague, Czechia
- Novartis Investigative Site
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Saint-Herblain Cedex, France
- Novartis Investigative Site
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Toulouse, France
- Novartis Investigative Site
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Barcelona, Spain
- Novartis Investigative Site
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London, United Kingdom
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed, locally advanced, progressive or metastatic colon cancer, up to 4 prior lines of prior chemotherapy, at least one measurable lesion according to RECIST
- Age ≥ 18 years
- Life expectancy ≥ 12 weeks
- WHO performance status of 0-1
- Negative serum pregnancy test
- Adequate hepatic or renal function and hematological parameters
Exclusion Criteria:
- Brain metastases
- Ileostomy or colonostomy
- History of pelvic radiotherapy
- Grade > 1 diarrhea at baseline
Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Bolus
20 min bolus infusion
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Experimental: CIV-1d
1 day continuous infusion
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Experimental: CIV-5d
5 day continuous infusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To identifymaximum tolerated dose (MTD)
Time Frame: During cycle 1 and 2 (approx 6 to 8 wks)
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During cycle 1 and 2 (approx 6 to 8 wks)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To characterize the safety and tolerability of patupilone by assessing adverse events (AEs) and serious adverse events (SAEs), hematology and biochemistry labs, vital signs, performance status, and by physical/neurological exams
Time Frame: at base line, every 3 weeks prior to start of the next dose, at end of treatment
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at base line, every 3 weeks prior to start of the next dose, at end of treatment
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To evaluate preliminary anti-tumor activity of patupilone using standard imaging technologies (e.g. best overall response rate and time to progression according to Response Evaluation Criteria in Solid Tumors [RECIST])
Time Frame: at baseline and every 8 wks
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at baseline and every 8 wks
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To evaluate the blood concentrations profile (pharmacokinetics [PK]) of patupilone by multiple blood sampling before, during and after drug administration
Time Frame: Cycle 1 and 4
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Cycle 1 and 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Novartis Pharmaceuticals, Royal London Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2003
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
August 10, 2009
First Submitted That Met QC Criteria
August 27, 2009
First Posted (Estimate)
August 31, 2009
Study Record Updates
Last Update Posted (Actual)
December 8, 2020
Last Update Submitted That Met QC Criteria
December 6, 2020
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Colonic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Epothilone B
Other Study ID Numbers
- CEPO906A2117
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colon Cancer
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National Cancer Institute (NCI)NSABP Foundation IncCompletedColon Adenocarcinoma | Stage IIIA Colon Cancer AJCC v7 | Stage IIIB Colon Cancer AJCC v7 | Stage IIIC Colon Cancer AJCC v7 | Stage IIA Colon Cancer AJCC v7 | Stage IIB Colon Cancer AJCC v7 | Stage IIC Colon Cancer AJCC v7United States
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Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
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Gruppo Oncologico del Nord-OvestSeagen Inc.; Servier; Foundation MedicineRecruitingStage II Colon Cancer | Stage III Colon Cancer | HER2-positive Colon Cancer | RAS Wild-type Colon CancerItaly
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)CompletedFatigue | Depressive Symptoms | Stage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Psychosocial Effects of Cancer and Its Treatment | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage I Colon Cancer | Stage... and other conditionsUnited States
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Hospital da Senhora da OliveiraCompletedColon Cancer | Colon Adenoma | Colon Polyp | Colon Rectal CancerPortugal
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)RecruitingStage III Colon Cancer AJCC v8 | Colon Adenocarcinoma | Microsatellite Stable Colon Carcinoma | Stage IIB Colon Cancer AJCC v8 | Stage IIC Colon Cancer AJCC v8United States
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National Cancer Institute (NCI)CompletedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer | Stage IVB Colon Cancer | Stage IVB Rectal CancerUnited States
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Howard S. Hochster, MDRecruitingStage IV Colon Cancer AJCC v8 | Stage IVA Colon Cancer AJCC v8 | Stage IVB Colon Cancer AJCC v8 | Stage IVC Colon Cancer AJCC v8 | Metastatic Colon CarcinomaUnited States
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NorgineXolomon Tree S.L.CompletedColon Cancer | Colon Disease | Colon CleansingSpain, Portugal
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